The American Food and Drug Administration estimates that ten percent of all medications worldwide are falsified. With the Falsified Medicines Directive (FMD) 2011/62/EU, the European Union has taken a stand against falsification to protect patients from imitations containing dangerous ingredients or without any active agents at all.
As of February 2019, EU member states and the states of the European Economic Area are obligated to verify prescription drugs via a connected Europe-wide database system EU-Hub (the European Hub). Switzerland also plans on committing to this regulation by 2020, requiring all Swiss manufacturers and wholesalers to connect to the EU-Hub.
In practice, the new regulation means that all prescription medicinal products for human use are equipped with two security features:
- A two-dimensional QR code including the product code, the serial number, the batch number and the expiration date
- Manipulation protection in the form of a seal applied to the pharmaceutical packaging
Current situation in Switzerland
With Article 17a of the Federal Act on Medicinal Products and Medical Devices (HMG), Switzerland has a law that corresponds to European Directive 2011/62/EU, but compliance is still voluntary. Currently being developed, implementation provisions are expected to enter into force in 2020. All Swiss market authorization holders, that is manufacturers, and wholesalers are obligated to meet shipment tracking requirements as per Art. 17a HMG and Directive 2011/62/EU. This includes:
- Equipping all prescription medications with the aforementioned QR code and manipulation protection
- Connecting manufacturers and wholesalers to the EU-Hub
- Validating all prescription medications before dispensing them to end customers
FMD requirements for the EU-Hub
As Fig. 1 shows, in the future, Swiss pharma manufacturers and wholesalers will have to upload data related to medicines to the EU-Hub. The medications are scanned at all authorized dispensaries, such as pharmacies, hospitals and doctor’s offices, validated and finally decommissioned from the European database. This prevents falsified medicines from being dispensed to patients. In addition, the FMD will also enable transparency in terms of the exact point where such a product enters the supply chain.
Dispensaries will be integrated into the European database by national, non-profit organizations and systems of each member state. All national data repositories are connected by the cloud-based EU-Hub, ensuring international data exchange. The Swiss Association for the Verification of Medicinal Products runs its own data repository system containing all prescription medicines marketed in Switzerland and Liechtenstein. In Germany, Securepharm provides the national software infrastructure.
Fig. 1: The EU-Hub is a connected Europe-wide database system for tracing medicines from manufacturers to distributors and verifying them (click to enlarge).
By contrast, manufacturers are connected directly to the EU-Hub. The European Medicines Verification Organisation (EMVO) is responsible for integration and the interface to manufacturers. As a result, all medicine manufacturers have to go through a complex, multi-stage onboarding and legitimation process by 2020 at the latest to prove to the EMVO that they can ensure constant data transfer.
This process as well as the IT infrastructure requirements should not be underestimated. Over ten years, a typical pharma company with an annual production of 125 million medicines produces a volume of 6.5 TB of data for serial numbers alone. The FMD also stipulates the constant exchange of master data, batch numbers, legitimacy information, alert data and query transactions. As such, ensuring continuous, error-free data exchange between manufacturers or wholesalers and the EU-Hub requires lean processes and a state-of-the-art infrastructure capable of handling large data volumes, and a software solution tailored to the company’s specific needs that captures serialization data and is connected to the EU-Hub.
As part of a partnership with TraceLink, ARCONDIS supported multiple serialization projects at medium-sized pharma companies in Germany, Austria and Switzerland. The typical challenge: As market authorization holders, the companies were obligated to upload all commissioned serial numbers to the EU-Hub effective February 9, 2019. But the greatest challenge wasn’t generally procuring an interface to the EU-Hub itself, but connecting to numerous partners, contract manufacturers or license holders in other EU countries. Besides technical interfaces, the main key to success was clean, patient communication between all involved parties.
You’d like to learn more about FMD requirements, our service range and reference projects? Contact us!
This may also interest you: